NCT05309863Recruiting
Comparison Between the Efficacy of Residential and Ambulatory Weight Loss Programs for Pediatric Non-alcoholic Fatty Liver Disease
Source: ClinicalTrials.gov · Last updated 4 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Non-alcoholic fatty liver disease (NAFLD) has become the most prevalent chronic liver disease worldwide, paralleling the obesity pandemic. Secondary to increasing rates of obesity in children and adolescents, the prevalence of NAFLD has more than doubled in the last decades and is now the most common pediatric liver disease. At present, lifestyle modification by dietary intervention and increasing physical activity is the mainstay of treatment for pediatric NAFLD. Several studies have shown that lifestyle intervention and weight loss improve non-invasive markers of NAFLD. To the investigator's knowledge, data on fibrosis regression following lifestyle treatment in children and adolescents were lacking. The investigators therefore performed a prospective cohort study to investigate the impact of residential lifestyle treatment on liver steatosis and fibrosis in obese children and adolescents. As a follow-up, the investigators now aim to compare these findings with a cohort of well-characterized patients undergoing multidisciplinary, yet ambulatory, weight loss treatment. As such, the investigators will compare the outcomes in two prospective patient cohorts in this non-randomized observational study.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 850 (estimated)
- First submitted
- 25 Mar 2022
- Start date
- 1 May 2022
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- University Hospital, Ghent
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05309863
What you commit to
- Study type: Observational
- Planned participants: 850
- From 1 May 2022 to the primary completion date, 31 Dec 2030
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with drugs which can induce liver steatosis or fibrosis (e.g. systemic corticosteroids, methotrexate)
Other illness
- Evidence of liver disease of other causes (viral, auto-immune, genetic)
Other
- Syndromic obesity
- Average daily alcohol consumption of \>20g/day
- Unvalid screening Fibroscan
Who the study is looking for
- Enrolled in the lifestyle management program for obesity in one of the participating centres
Age in the registry: 8 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zeepreventorium Coordinator of this site? Confirm its status | De Haan | Belgium | Recruiting |
| University Hospital Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
| AZ Jan Palfijn Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.